Tobacco and Sperm Genome: Effects of Smoking Cessation

NCT03552081 | Completed

• 1 other identifier: RC31/17/0344
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking.

Conditions

Male Infertility

Keywords

spermatogenesis; tobacco; DNA Fragmentation Index

Outcome Measures

Primary Outcomes (3)

• Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation

  TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 12 months after smoking cessation

  Up to 12 months after smoking cessation

• Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 3 months after smoking cessation

  TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 3 months after smoking cessation

  Up to 3 months after smoking cessation

• Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 6 months after smoking cessation

  TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 6 months after smoking cessation

  Up to 6 months after smoking cessation

Secondary Outcomes (6)

• Rate of 8-OHdG gamete DNA

  Up to 12 months after smoking cessation

• Spermogram exam

  Up to 12 months after smoking cessation

• Fragmentation index (DFI) of gamete DNA

  Up to 12 months after smoking cessation

• Aneuploid sperm count

  Up to 12 months after smoking cessation

• luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels

  Up to 12 months after smoking cessation

Study Arms (1)

fragmented DNA evaluation in blood and semen samples

EXPERIMENTAL

20 men followed for smoking cessation will be included in the study in order to evaluate the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking

Other: Fragmented DNA evaluation in blood and semen samples

Interventions

Fragmented DNA evaluation in blood and semen samples OTHER

The objective will be to evaluate the decrease in the percentage of sperm with spermatic DNA fragmentation by the TUNEL technique following the evolution of this rate to 3 months, 6 months and 12 months after cessation of smoking by blood and semen samples.

fragmented DNA evaluation in blood and semen samples

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• st Consultation in the Tobacco Control Co-ordination Unit,
• Affiliate or beneficiary of a social security scheme
• Free, informed and written consent signed by the participant and the investigator

You may not qualify if:

• antecedent consultation for male infertility,
• BMI\> 30,
• Medical and / or surgical history that can alter spermatogenesis -Chemotherapy / Radiation Therapy / IRA-therapy, Cryptorchidism, testicular Torsion, significant varicocele, chronic, progressive disease,
• hypovolemia \<1.6ml
• Major persons protected by law (guardianship, curators, safeguarding of justice)
• Co-addiction (cannabis, alcohol, other drugs)
• Neuropsychiatric Pathology, considered serious by the investigator
• Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse, Service de médecine de la reproduction

Toulouse, France

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jessica Moreau, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 11, 2018
• Study Start: October 2, 2018
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

FR (1)